(72 days)
The Tamaryn I.V. Flow Regulator Extension Set is used to control the flow rate of administration infusion fluids to a patient during a gravity intravenous infusion.
Tamaryn I.V. Flow Regulator Extension Set
I am sorry, but based on the provided FDA letter for K971066, a submission for the "Tamaryn I.V. Flow Regulator Extension Set," I cannot provide the detailed information requested regarding acceptance criteria and study data.
This document is a 510(k) clearance letter, which indicates substantial equivalence to a predicate device. It does not contain the detailed study data, acceptance criteria, or performance metrics that would be part of a submission dossier. The letter confirms that the device can be marketed but does not elaborate on the specific tests or their results.
Therefore, I cannot populate the table or answer the specific questions about sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details. This information would typically be found in the 510(k) summary or the full submission, which is not provided here.
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.